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ACTIVE NOT RECRUITING
NCT06284304
NA

A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

Summary

Trial design: A single centre phase II non-randomised study Trial population: Men with intermediate risk localised prostate cancer Recruitment target: 20 patients in total Trial objectives: * Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects * Secondary * To assess levels of acute GU and GI toxicity (CTCAE) * To assess levels of late GU and GI toxicity (CTCAE) * To assess late sexual quality of life (expanded EPIC, IIEF-5) * To assess biochemical relapse-free survival at 2 years Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-02-29

Completion Date

2027-04-02

Last Updated

2026-02-04

Healthy Volunteers

No

Conditions

Interventions

RADIATION

De-escalated radiotherapy

5 fraction de-escalated dose SBRT protocol

Locations (1)

Netherlands Cancer Institute

Amsterdam, Netherlands